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Replay of the live webcast on the STENOVA OLE results on October 1 available here

PR

Agomab to Participate in Upcoming Investor Conferences

Antwerp, Belgium, November 4, 2026 – Agomab Therapeutics NV (Nasdaq: AGMB) (“Agomab”), a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced that members of the management team will participate in the following upcoming investor conferences:

• Guggenheim 3rd Annual Healthcare Conference. Fireside chat on Tuesday, November 10, 2026 at 3:30 PM ET in Boston, MA.

• 2026 Jefferies Global Healthcare Conference. Wednesday, November 18, 2026 in London, UK.

• 9th Annual Evercore Healthcare Conference. Fireside chat on Tuesday, December 1, 2026 at 4:15 PM ET in Miami, FL.

• Piper Sandler 38th Annual Healthcare Conference. Fireside chat on Thursday, December 3, 2026 at 12:30 PM ET in New York, NY.

PR

Agomab Announces First Patient Dosed in Global NOV-ERA Phase 2b Study of Ontunisertib in Fibrostenosing Crohn's Disease

  • NOV-ERA is designed to assess the efficacy and safety of ontunisertib in approximately 320 patients with symptomatic Fibrostenosing Crohn’s disease (FSCD)
  • Global, randomized, placebo-controlled, dose-ranging study to evaluate three dose levels of ontunisertib, with endoscopic passability at Week 24 as primary endpoint
  • Study initiation represents an important milestone in the development of ontunisertib as a potential first targeted anti-fibrotic treatment for FSCD

Antwerp, Belgium, October 13, 2026 – Agomab Therapeutics NV (‘Agomab’), a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced that the first patient has been dosed in NOV-ERA, the Company’s global Phase 2b study evaluating ontunisertib in patients with symptomatic FSCD.
NOV-ERA is a randomized, double-blind, placebo-controlled, multicenter Phase 2b study designed to assess the safety and efficacy of ontunisertib. The study is expected to enroll approximately 320 adult patients globally. Participants will be randomized to receive either ontunisertib at one of three dose levels (400 mg BID, 200 mg BID, and 100 mg BID), or a matching placebo for a treatment duration of
52 weeks.
The initiation of NOV-ERA follows the positive Phase 2a STENOVA results that support continued clinical development of ontunisertib in FSCD. The recently announced positive long-term safety and tolerability findings of the open-label extension (OLE) part of the STENOVA Phase 2a study provide strong support for the inclusion of a 400 mg BID treatment arm in the NOV-ERA study.

PR

Agomab to Present STENOVA Open-Label Extension Data of Ontunisertib at UEG Week 2026 and Host Scientific Symposium on Fibro-Inflammation

Open-Label Extension (OLE) Data of STENOVA Phase 2a study with ontunisertib in Fibrostenosing Crohn’s disease (FSCD) selected for oral presentation at UEG Week 2026
Results support initiation of global NOV-ERA Phase 2b study in FSCD
Agomab-sponsored symposium to discuss the importance of targeting fibro-inflammation in inflammatory bowel disease (IBD)

Antwerp, Belgium, October 8, 2026 – Agomab Therapeutics NV (‘Agomab’) a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced that OLE data of the Phase 2a STENOVA study will be presented in an oral session at United European Gastroenterology (UEG) Week 2026, taking place October 17-20 in Barcelona, Spain. The OLE study (Part B of STENOVA) evaluated long-term treatment with ontunisertib 200 mg BID for up to 60 weeks in symptomatic FSCD patients. The study assessed the long-term safety and PK profile of ontunisertib and explored the event rate and disease progression in FSCD patients.

“Our goal is to improve the lives of patients with fibrotic diseases. We are aiming to build a leading company that combines transformative science with the commitment and passion of our experienced team, partners, and investors.”

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Tim Knotnerus, Chief Executive Officer